Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an

FDA device recall Z-2792-2016 · posted 2016-09-13 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.

Action taken

The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 30, 2016 by e-mail to its customer requesting that they quarantine affected devices and sent the letter via UPS (with return receipt) on July 1, 2016. The letter described the product, problem and actions to be taken. The customer was instructed to inform users of the Medical Device Removal and forward the notice to all who need to be aware; inspect your inventory and return affected products to Stryker Orthopaedics/PFA Product Returns, Attn: Distribution Inventory Team; 325 Corporate Drive; Dock M-East , Mahwah, NJ 07431 REF: PFA #2016-094; complete and return the Business Reply Form via email to SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com within 5 days; and keep a copy of the completed and executed Business Reply Form for your records. If you have any questions, feel free to contact the Mgr., Divisional Regulatory Compliance, Marketing Quality at (201) 831-6693.

Root cause

Labeling mix-ups

Status

Terminated

Product code

HSB

Quantity affected

1 unit in total

Distribution

US distribution to state of: CA.

Date initiated

2016-06-30

Date posted

2016-09-13

Date terminated

2017-06-21

Location

Mahwah, NJ

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